Ipilimumab vs Ipilimumab Plus Nivolumab in Patients With Stage III-IV Melanoma Who Have Progressed or Relapsed on PD-1 Inhibitor Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02731729|
Recruitment Status : Completed
First Posted : April 7, 2016
Results First Posted : February 21, 2021
Last Update Posted : February 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: ipilimumab Drug: nivolumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Phase 2 Study of Ipilimumab vs Ipilimumab Plus Nivolumab in Patients With Stage III-IV Melanoma Who Have Progressed or Relapsed on PD-1 Inhibitor Therapy|
|Actual Study Start Date :||June 21, 2016|
|Actual Primary Completion Date :||August 27, 2018|
|Actual Study Completion Date :||February 13, 2019|
Experimental: ipilimumab and nivolumab
For patients in the combination arm, nivolumab will first be administered intravenously at a dose of 1 mg/kg of body weight over a period of 60 minutes, once every 3 weeks for four doses. Thirty minutes after the completion of each nivolumab infusion, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes.
Other Name: Yervoy
Other Name: Opdivo
In the ipilimumab monotherapy group, patients will receive 3 mg/kg of ipilimumab over a period of 30 minutes once every 3 weeks for four doses.
Other Name: Yervoy
- Overall Response Rate (ORR) as Defined by RECIST v1.1 at Week 18 [ Time Frame: Week 18 ]Overall Response Rate was defined as any participant who had a Complete Response (CR) or Partial Response (PR) as defined by RECIST v1.1 by week 18 of treatment.
- Disease Control Rate (DCR) Status at Week 18 [ Time Frame: Week 18 ]Disease Control Rate was defined as any participant who achieved a complete response (CR), partial response (PR), or who remained stable (SD) as defined in Recist v1.1 at week 18.
- Time to Treatment Failure (TTF) [ Time Frame: The time from treatment initiation until a subsequent therapy is started or death. ]Time to Treatment Failure is defined as the time from treatment initiation until the participant starts a subsequent therapy or death, whichever comes first.
- Overall Survival (OS) [ Time Frame: Death ]Overall Survival is defined as the time of treatment initiation to death by any cause
- Number of Participants With Grade 3 or 4 Adverse Events [ Time Frame: AE were monitored during each treatment cycle and could be reported until 30 days after the last dose of study treatment had been administered. ]The occurrence of Grade 3 and Grade 4 adverse events (AE) assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
- Disease Control Rate (DCR) Status at Week 12 [ Time Frame: Week 12 ]Disease Control Rate was defined as any participant who achieved a complete response (CR), partial response (PR), or who remained stable (SD) as defined in Recist v1.1 at week 12.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02731729
|United States, California|
|University of California, Los Angeles|
|Los Angeles, California, United States, 90095|
|University of California, San Francisco|
|San Francisco, California, United States, 94134|
|United States, New Jersey|
|Memorial Sloan Kettering Basking Ridge|
|Basking Ridge, New Jersey, United States, 07920|
|United States, New York|
|Memorial Sloan Kettering Westchester|
|Harrison, New York, United States, 10604|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, Pennsylvania|
|Lehigh Valley Health Network|
|Allentown, Pennsylvania, United States, 18103|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Study Director:||Ramy Ibrahim, MD||Parker Institute for Cancer Immunotherapy|